PINNACLE 2217-28-047Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295520221), received between Mar 23, 2021 and Apr 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HEAD TRIAL WAS STUCK IN THE DM LINER TRIAL AND CANNOT BE EXTRACTED. BOTH PIECES NEED TO BE REPLACED. THEY WERE NOT USED ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21873124 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THE PINNACLE MB HEAD TRIAL IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402657 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HEAD TRIAL STUCK IN POLY BALL TRIAL. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20278221 ↗
• MalfunctionJul 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE 47 MOBILITY TRIAL WAS DAMAGED. INTERNAL BALL KEPT DISASSEMBLING WHEN TRIALING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826613 ↗
• MalfunctionApr 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENT STUCK INSIDE OF ANOTHER INSTRUMENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197213 ↗
• MalfunctionJun 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PINNACLE MB HEAD TRIAL 47/28 IS STUCK ON THE DM HEAD TRIAL INSERTION TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164187 ↗
• MalfunctionJan 5, 2022Peeled/Delaminated; Peeled/Delaminated

  DUAL MOBILITY HEAD TRIAL IS BURNED AND IS AT RISK OF PIECES FLAKING OFF WHILE TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171913 ↗
• MalfunctionAug 20, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TIP OF CARDAN SCREWDRIVER WAS DAMAGED AND CAUSED SCREWS TO STICK TO TIP. NEEDS TO BE REPLACED. 47/28 PDM TRIAL IS DAMAGED AND NEEDS TO BE REPLACED. IT HAS GROOVES IN IT THAT CAUSE IT TO NOT ARTICULATE SMOOTHLY. WITH A 3 MINUTES DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350905 ↗
• MalfunctionMar 23, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THERE WERE NO REFERENCE MARKINGS ON THE INSTRUMENT UPON OPENING OF THE PACKAGING. THE INSTRUMENT WAS NOT INVOLVED IN A PROCEDURE. NO SURGICAL DELAYS OR PATIENT CONSEQUENCES ASSOCIATED WITH THE MISSING REFERENCE NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555650 ↗